The main purpose of this Phase III study is to evaluate the safety and efficacy of pimagedine, as compared to placebo, in patients with Type II diabetes mellitus and overt diabetic nephropathy. The primary objective will evaluate the effect of pimagedine on the time to double the serum creatinine. The effects of pimagedine on advanced glycosylation end-products (AGE), all cause mortality, and cardiovascular mortality and morbidity will also be assessed.